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At-Home Flu Tests Give Health Systems Opportunities to Innovate

Analysis  |  By Mandy Roth  
   July 16, 2018

HHS funds development of testing devices, which could impact the way health systems respond through population and telehealth initiatives, plus other innovations.

Flu season typically packs emergency departments and urgent care centers with sick patients, who, in turn, spread the very infection the health system is attempting to quell. Thanks to two over-the-counter diagnostic tests for influenza under development with support from the U.S. Department of Health and Human Services (HHS), the future may look very different, presenting health systems and hospitals opportunities to activate population health and telehealth initiatives, as well as pharmacy innovation.

With the advent of at-home influenza testing, many patients may:

  • Conduct their own flu tests at home, keeping them out of healthcare facilities and reducing exposure among those who are uninfected;
  • Consult with their physicians via phone or telehealth, armed with a definitive diagnosis; and
  • Obtain anti-viral drugs earlier, when they are most effective.

Faster Diagnosis Means More Effective Treatment

"Influenza is a major killer of many people every single year, yet many people have no knowledge or awareness when they've been infected," says Rick A. Bright, Ph.D., deputy assistant secretary for the HHS Office of the Assistant Secretary for Preparedness and Response and director of the Biomedical Advanced Research and Development Authority (BARDA), the entity that is funding development of the at-home tests.

Bright spoke to HealthLeaders last month about other BARDA initiatives in a discussion that also addressed influenza.

"The diagnostics that we have [today] are in centralized laboratories, public health laboratories or, at the best, in an emergency care setting," says Bright. "Patients don't have access to those tools in time to get appropriate treatment. The drugs to treat influenza are most effective if used within 48 hours of symptoms. We believe by driving diagnostics and indicators out of the centralized laboratories into the home… they will be empowered to get treated sooner when the drugs are more effective."

Innovation at Work

BARDA is partnering with Cue Health Inc., of San Diego, California, and Diassess Inc., of Emeryville, California, to develop these first-in-class influenza testing devices. According to HHS:

  • BARDA will provide $14 million to Cue Health and $10 million to Diassess for advanced development of diagnostic tests for influenza A and B viruses that are being developed for purchase over-the-counter or administration by professionals. The investment with both companies may be extended.
  • Devices and tests will be inexpensive, simple for consumers to use, and able to give results within 25 minutes.
  • Both devices leverage mobile technology so that patients who test positive for influenza can receive a telemedicine consultation and, if needed, a prescription for antiviral drugs without leaving home.

At-home delivery or curb-side pickup of medications could further reduce the spread of infection.  

Health System Impact and Opportunities

Once home-testing capabilities are available, health systems would have a better method to limit exposure of patients to employees who have influenza, as well as experience fewer employee sick days and diminish lost workforce productivity. While fewer patients may show up in EDs and urgent care, those who do are likely to be more acutely ill.

In addition, there may be opportunities for health system innovation by:

  • Utilizing self-diagnostic devices to support population health initiatives targeted to high risk patients, including those with COPD;
  • Exploring opportunities to employ telehealth services in conjunction with at-home testing; and
  • Exploring pharmacy innovations to deliver drugs at home, curbside or in other ways to further diminish the spread of infection.

According to an article published last month in Vaccine, the estimated average annual total economic burden of influenza to the healthcare system and society was $11.2 billion in 2015. Direct medical costs were estimated to be $3.2 billion and indirect costs $8.0 billion.

These total costs were based on the estimated average numbers of ill/non-medically attended patients (21.6 million), office-based outpatient visits (3.7 million), emergency department visits (0.65 million), hospitalizations (247,000), deaths (36,300), and days of productivity lost (20.1 million).

More Innovation Opportunities on the Horizon

"We've been very successful in making drugs and vaccines and diagnostics to address the many national health security threats," says BARDA's Bright. "However, there are still significant, systemic gaps that are preventing their effective use when and where they're needed. BARDA believes by addressing the framework, identifying early when someone is exposed to a pathogen, a virus or bacteria, identifying and characterizing that organism as quickly as possible, manufacturing drugs and vaccines more efficiently and making sure individuals have access to those, then we will save more lives.

"When you're infected with something, every minute can make a difference in life and death," Bright continues. "We believe that there are technologies today that can reduce the footprint of how we manufacture drugs so much that we could eventually get to an ATM-like module in every corner drugstore that will synthesize your prescription on demand."

Health system innovation centers may wish to explore opportunities to partner with BARDA, which seeks innovative products in advanced stages of development for use in combating pandemic influenza and emerging infectious diseases. Learn more through the BARDA Broad Agency Announcement.

Mandy Roth is the innovations editor at HealthLeaders.

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